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Zydus Lifesciences bags US FDA approval for menopause drug

Zydus Lifesciences bags US FDA approval for menopause drug

United States Food and Drug Administration (US FDA) has given Zydus Lifesciences (formerly Cadila Healthcare Limited) final approval to market Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.

The Estradiol Transdermal System is used to treat moderate to severe menopausal symptoms such as feelings of warmth in the face, neck, and chest, as well as sudden strong feelings of heat, hot flushes and vaginal dryness in women. The drug will be manufactured in Moraiya, Ahmedabad, at the group's formulation manufacturing facility.

Since the beginning of the filing process in FY 2003-04, the group has so far received 336 approvals and has filed over 431 ANDAs.

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US FDA Zydus Lifesciences
More news about: quality / gmp | Published by Sudeep Soparkar | December - 05 - 2022 | 692

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